One of Sen. Ted Kennedy's top committee aides will take a major role in the new FDA. David Dorsey, who's already been "detailed" to the FDA on behalf of Sen. Kennedy, will be developing agency policy and working with Congress in his new role, according to RPM Report. He'll also be a top counselor to acting FDA Commish Joshua Sharfstein.
By virtue of his previous work in the agency's Office of the Chief Counsel, Dorsey has a wealth of nitty-gritty knowledge, both about the agency's workings and about the legislation that governs it. He played key roles in developing the PDUFA reauthorization in 2002 and the big drug-safety reforms in 2007's FDA Amendments Act. As a co-author of the risk management strategies instituted by FDAAA, he's intimately familiar with their requirements. Plus, he's been involved in the copycat biologics debate; he worked on Kennedy's compromise bill that included 12 years of market exclusivity for biologic drugs before bioequivalent competitors would be allowed onto the market.
Dorsey's current appointment doesn't necessarily mean that he won't be named FDA Chief Counsel as some had expected. But that job will probably lack a permanent appointee until a general counsel for HHS is named. In the meantime, career FDA attorney Michael Landa is expected to be made Acting FDA Chief Counsel, RPM reports.
- see the story at RPM